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OpenTrials
Completed

NCT Number: NCT01639625

Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application

They include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy External radiation therapy + more QT based weekly cisplatin.

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Key information

Age range

21 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Instituto de Oncologia Angel H. Roffo

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1417DTB, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stages IIA and IIB FIGO classification.
  • Age between 21 to 70 years.
  • ECOG performance status 0-1.
  • No history of another neoplastic disease.
  • Value of Hemoglobin ≥ 9 g / l.
  • Total leukocyte count ≥ 3.0 x 109 / L.
  • Absolute neutrophil count ≥ 1.5 x 109 / L.
  • Platelets ≥ 100,000 x mm3.
  • Total bilirubin ≤ 1.5 times ULN, SGOT and SGPT ≤ 2.5 times upper limit of normal.
  • Creatinine ≤ 2 mg / dL and creatinine clearance calculated ≥ 60 ml / min(according to Cockcroft-Gault formula)
  • Patients of childbearing age who are using an adequate contraception method during treatment to prevent pregnancy.
  • Life expectancy ≥ 12 months
  • Measurable disease
  • Informed consent signed by the patient

Exclusion criteria

  • Pregnancy and lactation period.
  • Presence of lymph node metastases or hematogenous extrapelvic known.
  • Uncontrolled intercurrent diseases, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric illness involving incompetence of the patient.
  • Other malignancies, with the exception of basal cell carcinoma or other tumor that appropriate treatment is received showing a disease-free period ≥ 5 years.
  • Hepatitis B or C active, positive serology for HIV.
  • Atopy history of severe / severe asthma.
  • A history of autoimmune disease.
  • Presence of significant abnormalities in ECG performed within 14 days prior to admission.
  • Diseases that prevent the patient give informed consent or their ability to collaborate in the trial.
  • Participating in another clinical trial "

Treatment and study plan

CIGB300

Drug

CIGB300: 15 mg, 35 mg and 70 mg All groups will receive CIGB-300 for local application.

Primary outcomes

  1. Number of patients with presence or absence of grade 3 or 4 adverse events related to the study drug, in each dose level

    Time frame: Up to 2 years

Secondary outcomes

  1. Number of patients with local relapses

    Time frame: Up to 2 years

  2. Number of patients with distant relapses

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Laboratorio Elea Phoenix S.A.

Industry

Registry information

Official study title

Open Clinical Trial, Uncontrolled in Patients Bearing Squamous Cell Carcinoma or Adenocarcinoma of the Cervix Stage IIA and IIB FIGO Classification Treated With Radiotherapy External Endocavitary Brachytherapy + Concurrent Hemotherapy Weekly Systemic and Local Application of CIGB-300 Dose Escalation

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jul 13, 2012
Registry last updated
Aug 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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